Adoption of Anonymization for Innovation
Current disclosure requirements set by Health Canada and the European Medicines Agency have highlighted new processes necessary for anonymization and transparency. Recently, regulatory evidence has shown some disconnection between the two agencies. Sponsors are being asked to submit multiple versions of documentation, some have even been asked to provide their materials in Japanese. Overall, organizations are feeling more stress to maintain compliance and provide trial data to the public domain to fuel medical innovation.
If you’re interested in learning more about where transparency requirements are headed and how your organization stacks up, we put together a third party research study covering areas transparency sponsors consider highest priority, where they’re at currently with transparency efforts, and how they plan to meet different regulatory requirements and deadlines – now and in the future.
Objectives of the Research are as follows:
• Determine state of transparency adoption processes
• Assess how sponsors plan on meeting regulatory deadlines, both currently and in future
• Identify pain points around data transparency
· 12 transparency leads from different pharmaceutical companies
· Partnered with Informa CBI to on quantitative survey
· 1:1 interview with outside transparency consultants and regulatory advisors